Medication Monitor

Generic Name (Trade Name—Company)
February 27, 2019

Antihemophilic factor (recombinant), glycopegylated-exei

(Esperoct—Novo Nordisk)
New biologic for treatment of hemophilia A will be available in 2020

FDA approved antihemophilic factor (recombinant), glycopegylated-exei, for adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. It comes as a lyophilized powder for solution for I.V. use.

Approval was based on results from a clinical trial program that included 270 previously treated people with severe hemophilia A and more than 5 years of clinical exposure. The biologic provided effective routine prophylaxis in people with severe hemophilia A through a simple, fixed dosing regimen of one injection every 4 days in adults and adolescents or every 3 to 4 days (twice weekly) in children. It was well tolerated, and no safety concerns were identified.

The most frequently reported adverse reactions (≥1%) were rash, redness, itching, and injection-site reactions.

Novo Nordisk is expected to launch the product in 2020.